A New Modified Suture Bridge Technique

Rotator Cuff Tears Clinical Trial

Official title:

A New Modified Suture Bridge Technique for Medium-sized Rotator Cuff Tears: Functional and Radiological Outcomes of a Prospective Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04825249
• Other study ID #: zhangyi
• Status: Completed
• Phase: N/A
• Start date: December 30, 2018
• Est. completion date: January 5, 2021

Study information

• Verified date: March 2021
• Source: The Affiliated Hospital of Qingdao University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

We aimed to introduce a new modified suture bridge technique and report the clinical outcomes and radiological assessments of modified suture bridge technique for medium rotator cuff tears.

Description:

Purpose: We aimed to introduce a new modified suture bridge technique and report the clinical outcomes and radiological assessments of modified suture bridge technique for medium rotator cuff tears. Methods: We prospectively followed 50 consecutive patients with medium rotator cuff tears treated with the modified suture bridge (MSB) or traditional suture bridge technique (TSB) from December 2018 and December 2019. On the basis of preoperative findings and MRI performance, 26 patients underwent MSB repair whereas 24 underwent TSB repair. Range of shoulder motion, visual analog scale score (VAS score), University of California-Los Angeles score (UCLA score), Constant-Murley shoulder score (Constant score), American Shoulder and Elbow Surgeons score (ASES score) were assessed. Magnetic resonance imaging were performed preoperatively and at 12 months postoperatively.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: January 5, 2021
• Est. primary completion date: December 2, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• (1) full-thickness medium tears (1-3cm) of primary supraspinatus (SSP) tendon was identified on preoperative MRI and intraoperative arthroscopy, (2) undesirable conservative treatment for 3 months, (3)completed follow-up of 12 months postoperatively and patients who adhered to the rehabilitation plan.

Exclusion Criteria:

• (1) previous shoulder surgery, (2) Other pathological changes that would need to be addressed at the time of arthroscopic surgery, such as rotator cuff tear involving the subscapular (SSC) tendon,biceps tendon injury, (3) failure to follow our postoperative rehabilitation protocol and patients without regular follow-up.

Related Conditions & MeSH terms

• Rotator Cuff Injuries
• Rotator Cuff Tears

Intervention

Procedure:
• traditional suture bridge technique
(A) Limbs of the sutures from the medial anchor were passed through torn tendon (B) the suture limbs were tied in a horizontal mattress suture pattern (C) the lateral row pressed the free tails of the knotted line on the greater tubercle of the humerus (D) the effect after completion of the TSB technique
• modified suture bridge technique
(A) Limbs of the sutures from the medial anchor and 2 tendon sutures were passed through the same position of torn tendon (B) the lateral row pressed free tails of the two tendon lines on the greater tubercle of the humerus (C) after examination of sufficient tension and stable fixation, sutures of medial row was knotted (D) the effect after completion of the MSB technique

Locations

Country	Name	City	State
China	The Affiliated Hospital of Qingdao University	Shangdong

Sponsors (1)

Lead Sponsor	Collaborator
The Affiliated Hospital of Qingdao University

Country where clinical trial is conducted

China, 

References & Publications (3)

Dukan R, Ledinot P, Donadio J, Boyer P. Arthroscopic Rotator Cuff Repair With a Knotless Suture Bridge Technique: Functional and Radiological Outcomes After a Minimum Follow-Up of 5 Years. Arthroscopy. 2019 Jul;35(7):2003-2011. doi: 10.1016/j.arthro.2019. — View Citation

Kim KC, Shin HD, Lee WY, Yeon KW, Han SC. Clinical outcomes and repair integrity of arthroscopic rotator cuff repair using suture-bridge technique with or without medial tying: prospective comparative study. J Orthop Surg Res. 2018 Aug 28;13(1):212. doi: — View Citation

Takeuchi Y, Sugaya H, Takahashi N, Matsuki K, Tokai M, Morioka T, Ueda Y, Hoshika S. Repair Integrity and Retear Pattern After Arthroscopic Medial Knot-Tying After Suture-Bridge Lateral Row Rotator Cuff Repair. Am J Sports Med. 2020 Aug;48(10):2510-2517. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cuff integrity grade of MRI assessment	Grade I: sufficient thickness of tendon; Grade II: sufficient thickness of tendon and partial high intensity within tendon; Grade III: insufficient thickness of tendon without discontinuity; Grade IV: slight discontinuity in 1 or 2 images of oblique coronal plane and sagittal plane; Grade V:obvious discontinuity of tendons in more than 2 images of both oblique coronal plane and sagittal plane.	at 12 months postoperatively
Primary	Muscle atrophy grade of MRI assessment	Grade I: a ratio between 1.00 and 0.60 can be considered as normal or slightly atrophied; Grade II: values between 0.60 and 0.40 suggest moderate atrophy. Grade III: values below 0.40 indicate serious or severe atrophy.	at 12 months postoperatively
Primary	Fatty degeneration grade of MRI assessment	Grade 0: completely normal muscle; Grade 1: muscle contains some fatty streaks; Grade 2: there is more muscle than fat; Grade 3: equal distribution of fat and muscle; grade 4: more fat was present than muscle. Among them, grade 0 is normal, grade 1 and 2 are considered moderate, grade 3 and 4 are classified as severe.	at 12 months postoperatively
Primary	Range of shoulder motion	Different range of motion of shoulder joint	at 12 months postoperatively
Primary	The Visual Analog Scale score	Assess pain on a scale of 0 (no pain) to 10 (worst possible pain).	preoperatively
Primary	The Visual Analog Scale score	Assess pain on a scale of 0 (no pain) to 10 (worst possible pain).	at 12 months postoperatively
Primary	University of California-Los Angeles score	The score mainly consists of two parts. Patients subjectively evaluate pain and functional activity; and doctors objectively evaluate shoulder joint mobility and muscle strength. Possible scores range from 0 to 35, a higher score means a better result.	preoperatively
Primary	University of California-Los Angeles score	The score mainly consists of two parts. Patients subjectively evaluate pain and functional activity; and doctors objectively evaluate shoulder joint mobility and muscle strength. Possible scores range from 0 to 35, a higher score means a better result.	at 12 months postoperatively
Secondary	Constant-Murray Shoulder score	An assessment method often used by orthopedic surgeons when assessing the condition of patients with shoulder joints.Possible scores range from 0 to 100#a higher score means a better result.	preoperatively
Secondary	Constant-Murray Shoulder score	An assessment method often used by orthopedic surgeons when assessing the condition of patients with shoulder joints.Possible scores range from 0 to 100#a higher score means a better result.	at 12 months postoperatively
Secondary	American Shoulder and Elbow Surgeon score	The evaluation criteria used to assess shoulder joint function based on the patients' pain and accumulated daily activities. Possible scores range from 0 to 100. The higher the score, the better the shoulder joint function.	preoperatively
Secondary	American Shoulder and Elbow Surgeon score	The evaluation criteria used to assess shoulder joint function based on the patients' pain and accumulated daily activities. Possible scores range from 0 to 100. The higher the score, the better the shoulder joint function.	at 12 months postoperatively

External Links

•   Arthroscopic Rotator Cuff Repair With a Knotless Suture Bridge Technique: Functional and Radiological Outcomes After a Minimum Follow-up of 5 Years
•   Clinical outcomes and repair integrity of arthroscopic rotator cuff repair using suture-bridge technique with or without medial tying: prospective comparative study
•   Repair Integrity and Retear Pattern After Arthroscopic Medial Knot-Tying After Suture-Bridge Lateral Row Rotator Cuff Repair